DARA BioSciences Launches Soltamox®, First and Only Liquid Version of Tamoxifen Citrate

DARA BioSciences Launches Soltamox®, First and Only Liquid Version of Tamoxifen Citrate

An important option for people with breast cancer on tamoxifen therapy

RALEIGH, N.C.--(BUSINESS WIRE)-- Breast Cancer Awareness Month raises visibility and research dollars to address a disease that in the United States claims nearly 40,000 lives annually and affects approximately 240,000 people who each year are newly diagnosed. While the month's activities are important in the fight against breast cancer, they are not designed to directly improve the day-to-day management of the disease. But today, a liquid version of one of the most common drugs prescribed to fight breast cancer, tamoxifen, has for the first time become available in the United States under the brand name Soltamox® (tamoxifen citrate). Soltamox may offer patients who need tamoxifen therapy an important treatment option. Introduced by DARA BioSciences, Inc. (NAS: DARA) , a specialty pharmaceutical company focused on oncology and oncology supportive care products, Soltamox, a prescription medication, is expected to be available in pharmacies nationwide starting October 22.

Soltamox, liquid version of tamoxifen citrate (Photo: Business Wire)

Why liquid tamoxifen?

According to a 2011 study published in The Lancet, a five-year course of tamoxifen treatment in women with estrogen-receptor-positive breast cancer cut their risk of death by about one-third over a 15-year period. Unfortunately, for some people with breast cancer, the pill form of tamoxifen can be difficult to swallow due to a variety of reasons, including the effects of radiation, surgery and chemotherapy. Some people simply prefer liquid medications over pills or hope to reduce the number of pills they need to take on a daily basis.

Swallowing difficulties

Liquid medications may be appropriate for people who have difficulty or discomfort swallowing solid content. People who have trouble swallowing pills may miss doses of prescribed medications or discontinue them entirely. "Treatment of breast cancer with tamoxifen is a long-term commitment for patients if they are to have the best chance of preventing the disease from recurring," said oncologist Jivesh Sharma, MD, clinical faculty member at Presbyterian Hospital in Dallas, Texas. "A liquid version of tamoxifen may help people with breast cancer stay on their tamoxifen therapy."

Swallowing assessment tool

Unfortunately, many people are unaware that the inability to swallow pills and some foods can signal an underlying problem. But swallowing difficulties (sometimes called "dysphagia") may not always be obvious and may include "difficulty chewing solid foods and coughing while or after eating," according to Andrea Aversano, MS, RD, CDN, radiation/oncology dietician with Dyson Center for Cancer Care at Vassar Brothers Medical Center, Poughkeepsie, New York. "Many people may not even recognize they have a swallowing difficulty, even as they continue to lose weight or forego medication." She continued, "That is of particular concern for older, frailer adults or for people with compromised health."

Now a simple 10-question survey is available to help people assess if they may have a swallowing difficulty. The EAT-10 tool is clinically validated and can serve as a catalyst for dialogue with a healthcare provider. EAT-10 can be accessed at www.swallowingdifficulties.org.

DARA increased its focus in oncology through its January 2012 acquisition of Oncogenerix, Inc., which holds the exclusive U.S. marketing rights to Soltamox®, a novel oral liquid formulation of tamoxifen citrate, which is widely used in the treatment and prevention of breast cancer. Soltamox is the only FDA-approved oral liquid version of tamoxifen citrate and fulfills a vital clinical need for patients who cannot tolerate existing solid formulations of this drug. DARA is launching Soltamox in October 2012 to coincide with National Breast Cancer Awareness Month. DARA has exclusive U.S. rights to Soltamox through a license from Rosemont Pharmaceuticals, Ltd. Additionally, in June 2012, DARA launched its first product, Bionect®, a topical treatment for skin irritation and burns associated with radiation therapy. DARA has rights to market Bionect in the US oncology/radiology markets under license from Innocutis. In September 2012, DARA entered into an exclusive agreement with the Helsinn Group of Switzerland for U.S. commercial rights to Gelclair®, an FDA-cleared product for the treatment of oral mucositis. DARA plans to launch Gelclair in the first quarter of 2013.

Prior to acquiring Oncogenerix, DARA was focused on the development of a cancer-support therapeutic compound, KRN5500, for the treatment of neuropathic pain in patients with cancer. This product is an excellent fit with DARA's strategic oncology focus, has successfully completed a Phase 2a clinical trial, and has been designated a Fast Track Drug by the United States Food and Drug Administration. DARA is working with the National Cancer Institute (NCI) to design an additional clinical trial under joint DARA-NCI auspices while continuing further Phase 2 development.

In addition to its oncology products, DARA's pipeline includes DB959, a novel, non-TZD dual delta/gamma PPAR agonist for the treatment of type 2 diabetes and dyslipidemia. DARA has completed Phase 1 testing of DB959 and is presently pursuing opportunities to out-license this product.

All statements in this news release that are not historical are forward-looking statements within the meaning of the Securities Exchange Act of 1934, as amended. Such forward-looking statements are subject to factors that could cause actual results to differ materially for DARA from those projected. Those factors include risks and uncertainties relating to DARA's ability to timely commercialize and generate revenues or profits from Bionect®, Soltamox®, Gelclair®or other products given that DARA only recently hired its initial sales force and DARA's lack of history as a revenue-generating company, FDA and other regulatory risks relating to DARA's ability to market Bionect, Soltamox, Gelclair or other products in the U.S. or elsewhere, DARA's ability to develop and bring new products to market as anticipated, DARA's current cash position and its need to raise additional capital in order to be able to continue to fund its operations, the current regulatory environment in which DARA develops and sells its products, the market acceptance of those products, dependence on partners, successful performance under collaborative and other commercial agreements, competition, the strength of DARA's intellectual property and the intellectual property of others, the potential delisting of DARA's common stock from the NASDAQ Capital Market, risks and uncertainties relating to DARA's ability to successfully integrate Oncogenerix and other risk factors identified in the documents DARA has filed, or will file, with the Securities and Exchange Commission ("SEC"). Copies of DARA's filings with the SEC may be obtained from the SEC Internet site athttp://www.sec.gov. DARA expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DARA's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. DARA BioSciences and the DARA logo are trademarks of DARA BioSciences, Inc.